COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- March 21, 2023
- Posted
- May 10, 2023
- Recall Number
- Z-1578-2023
- Quantity
- 1186 units
- Firm Location
- Jordan, UT
Reason for Recall
Custom sheath Introducer contains incorrect needle size
Distribution
US Distribution to state of: Minnesota
Lot / Code Info
Lot # H2122096S1; UDI-DI: (00)884450525197
Root Cause
Unknown/Undetermined by firm
Action Taken
On March 21, 2023 MeritMedical issued a "Urgent Medical Device Recall Notice" to affected consignees via E-Mail. In addition to informing them about the recall, MeritMedical asked consignees to take the following actions: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed Customer Response Form to Customer Service at OEMorder@merit.com within seven (7) calendar days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF. 6. If you have any questions concerning this communication, please don t hesitate to contact your Merit OEM Sales Representative or Merit OEM Customer Service at (800)-637-4839| Hours: 8 am to 5 pm MST | Mon-Fri.